NDC 76348-447 Clixit Skin Care Acne Drying

Sulfur Acne Treatment

NDC Product Code 76348-447

NDC 76348-447-02

Package Description: 1 BOTTLE in 1 BOX > 28 g in 1 BOTTLE (76348-447-01)

NDC Product Information

Clixit Skin Care Acne Drying with NDC 76348-447 is a a human over the counter drug product labeled by Renu Laboratories, Inc.. The generic name of Clixit Skin Care Acne Drying is sulfur acne treatment. The product's dosage form is suspension and is administered via topical form.

Labeler Name: Renu Laboratories, Inc.

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Clixit Skin Care Acne Drying Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SULFUR 2.8 g/28g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • CAMPHOR (NATURAL) (UNII: N20HL7Q941)
  • ZINC OXIDE (UNII: SOI2LOH54Z)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
  • HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Renu Laboratories, Inc.
Labeler Code: 76348
FDA Application Number: part333D What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 10-02-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Clixit Skin Care Acne Drying Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active IngredientSulfur Colloidal 10%

Otc - Purpose

PurposeAcne Treatment

Indications & Usage

UseFor treatment of acne. Healing and drying of acne. Penetrates pores to control acne. Helps prevent breakouts.

Warnings

WarningsFor external use onlySkin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, contact physician or poison control center immediately.

Other Safety Information

Store at room temperature

Dosage & Administration

DirectionsClean the skin thoroughly before using. Cover affected areas with thin layer two or three times a day

Otc - Do Not Use

Do not use on broken skin or large areas of skin. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredient

Inactive IngredientsCamphor, Deionized Water, Hippophae Rhamnoides (Seaberry) Fruit and Seed Oil, Iron Oxide, Isopropyl Alcohol, Magnesium Aluminum Silicate, Salicylic Acid, Zinc Oxide.

Otc - Questions

QUESTIONSCall 844 425 4948

Statement Of Identity

Outer Box

Recent Major Changes

The only change was the removal of a punctuation mark in the Dosage and Administration section10/2019

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